Regeneron (REGN) and Sanofi (SNY) announced that the FDA has issued a Complete Response Letter for the supplemental Biologics License Application for Dupixent, or dupilumab, in chronic spontaneous urticaria. CSU is an inflammatory skin condition, which causes sudden and debilitating hives and swelling on the skin. The CRL states that additional efficacy data are required to support an approval; it did not identify any issues with safety or manufacturing. An ongoing clinical trial (Study C) continues to enroll patients, with results expected in late 2024 that are anticipated to provide the additional efficacy data.
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